August 4, 2020
Abiomed’s Impella Heart Pumps Receive FDA Emergency Use Authorization to Provide Unloading Therapy to COVID-19 Patients
August 4, 2020—Abiomed announced that the FDA has issued an emergency use authorization (EUA) for emergency use of the Impella left ventricular (LV) support systems. The EUA is intended for use by health care providers in the hospital setting for providing temporary LV unloading and support to treat critical care patients with confirmed COVID-19 infection who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and who develop pulmonary edema while on venoarterial ECMO support or late cardiac decompensation from myocarditis while on venovenous ECMO support.
The Impella LV support systems covered by the EUA include the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist systems.
The Impella combined with ECMO therapy (known as ECpella) is used as a tool for physicians treating COVID-19 patients with both heart and lung failure. The widespread inflammation caused by COVID-19 can result in damage to the lungs and heart that may cause severe LV dysfunction manifesting as pulmonary edema and/or myocarditis, noted the company.
“The early clinical evidence continues to accrue in favor of including LV unloading in many patients on ECMO,” commented Christian Bermudez, MD, in Abiomed’s announcement. Dr. Bermudez, who is Surgical Director of Lung Transplantation and ECMO and Professor of Surgery at the University of Pennsylvania in Philadelphia, Pennsylvania, continued, “The superior clinical outcomes from the combination of Impella and ECMO are likely the result of reducing the stress on the myocardium and work required of the left ventricle, also reducing secondary lung injury due to pulmonary congestion.”
Abiomed advised that this is the second EUA granted by the FDA for Impella during the COVID-19 pandemic. On June 1, the company announced that the FDA issued an EUA to expand the use of Impella RP to include patients with COVID-19–related right ventricular complications, including right ventricular dysfunction associated with pulmonary embolism.